# Clinical Protocol and Data Management

> **NIH NIH P30** · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · 2024 · $343,531

## Abstract

PROJECT SUMMARY: CLINICAL PROTOCOL AND DATA MANAGEMENT
The Clinical Protocol and Data Management (CPDM) system at Sylvester Comprehensive Cancer Center
(Sylvester) ensures patient safety, regulatory compliance, and data integrity in all clinical research. CPDM
aligns Sylvester’s clinical research portfolio with the distribution of cancer throughout the catchment area (CA)
in collaboration with the Sylvester Office of Outreach and Engagement (SOOE). Clinical Research Services
(CRS) oversees CPDM to provide a centralized, high-quality, infrastructure to support investigators in
developing, conducting, and reporting on clinical research with participant safety as the highest priority. The
specific aims are 1) oversee and strengthen Sylvester’s clinical research infrastructure and operations to
enable the conduct of clinical research trials in a timely and efficient manner; 2) provide investigators
centralized, high-quality clinical study services, including staffing and administrative support for the
development, activation, management, and reporting of clinical trials; 3) conduct quality assurance/quality
control assessments and train clinical research staff and investigators to deliver best practices in conducting
clinical studies and maintaining data accuracy and integrity; 4) ensure that all cancer research studies at
Sylvester are conducted and monitored in strict compliance with institutional policies, the Sylvester Data Safety
and Monitoring Plan (DSMP), and all state and federal regulations; and, 5) provide access to clinical studies for
all cancer patients regardless of age, gender, race, ethnicity, or primary language and proactively identify and
address barriers to study participation for individuals living in Sylvester’s CA. CRS supported 120 principal
investigators (PIs), 87 of whom enrolled patients to interventional treatment studies during the current reporting
period (6/1/2018-5/31/2023), the activation and completion of clinical protocols (293 active, enrolling protocols
at the end of the reporting period), accurate reporting of data, 15 site disease groups and four clinical research
teams, administration of research committees, and quality of all research. The Clinical Trials Coordination Unit
(CTCU) is focused on operations and regulatory support. The Research Operations Support Unit (ROSU)
facilitates administration of the Protocol Review and Monitoring Committee (PRMC) and Data and Safety
Monitoring Committee (DSMC). The Quality Management Unit (QMU) provides quality assurance, training for
staff and investigators, and compliance with Sylvester’s DSMP. CRS uses the clinical trial management
system, Velos eResearch, for participant, protocol, and monitoring requirements. During the reporting period,
Sylvester supported 2,292 interventional treatment, 2,476 interventional non-treatment, and 12,655 non-
interventional accruals reflecting the diversity and sociodemographic composition of the CA.

## Key facts

- **NIH application ID:** 10933325
- **Project number:** 2P30CA240139-06
- **Recipient organization:** UNIVERSITY OF MIAMI SCHOOL OF MEDICINE
- **Principal Investigator:** JONATHAN C TRENT
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $343,531
- **Award type:** 2
- **Project period:** 2019-07-10 → 2029-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10933325

## Citation

> US National Institutes of Health, RePORTER application 10933325, Clinical Protocol and Data Management (2P30CA240139-06). Retrieved via AI Analytics 2026-05-29 from https://api.ai-analytics.org/grant/nih/10933325. Licensed CC0.

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